ORG-9110A
Received Dec 4, 2025 · Event occurred Nov 13, 2025
Report 8030229-2025-05830 · MDR key 23723209
Device
Generic name
Multiple Patient Receiver
Manufacturer
Nihon Kohden CorporationModel number
ORG-9110ACatalog number
ORG-9110A
Lot number
NA
Product problems
- Communication or Transmission Problem
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAS AN ERROR LED LIT AND NOT ABLE TO MONITOR PATIENTS ON TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAS AN ERROR LED LIT AND NOT ABLE TO MONITOR PATIENTS ON TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL DEVICE INFORMATION: THE FOLLOWING FIELD(S) CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE ATTEMPT #1 11/17/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE ADDITIONAL DEVICE INFORMATION AS REQUESTED. TELEMETRY TRANSMITTER MODEL: ZM-521PA SN: NI TELEMETRY TRANSMITTER MODEL: ZM-531PA SN: NI.
Description of Event or Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAS AN ERROR LED LIT AND NOT ABLE TO MONITOR PATIENTS ON TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAS AN ERROR LED LIT AND NOT ABLE TO MONITOR PATIENTS ON TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: REPAIR CENTER EVALUATION DETERMINED THE CPU PCB HAD MALFUNCTIONED. THE CPU BOARD WAS REPLACED, THE UNIT WAS RECONFIGURED, AND FULL RECEPTION AND DISCLOSURE TESTING WAS COMPLETED. THE ORG PASSED EXTENDED TESTING AND QC BEFORE BEING RETURNED. A LOANER UNIT WAS PROVIDED DURING REPAIR. TELEMETRY TRANSMITTER MODEL: ZM-521PA SN: NI. TELEMETRY TRANSMITTER MODEL: ZM-531PA SN: NI. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE.